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Dabigatran and Warfarin Use Among Members with Atrial Fibrillation and Other Pre-Existing Conditions

    Basic Details
    Date Posted
    Medical Product

    Modular program-based one-time assessment of new use of the anticoagulants dabigatran and warfarin among individuals with a pre-existing condition of atrial fibrillation and other various pre-existing conditions, including anemia, chronic obstructive pulmonary disease (COPD), diabetes, hypertension, chronic kidney failure, acute kidney failure, peptic ulcer disease, acute myocardial infarction (AMI), heart failure, peripheral vascular disease, hospitalized stroke, urinary catheter, hospitalized bleed, chronic liver disease, hypercholesterolemia, malignancy, coronary revascularization, cerebral revascularization, transient ischemic attack (TIA), cerebrovascular disease, urinary incontinence, hospitalized pneumonia, cardioversion, cardioablation, intravenous (IV) anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors (PPIs), selective serotonin reuptake inhibitors (SSRIs), thyroid replacement medications, insulin, metformin, sulfonylureas, other diabetes medications, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), anti-arrhythmic, anti-platelet medications, beta-blockers, calcium channel blockers, digoxin, loop diuretics, potassium-sparing diuretics, thiazides, amiodarone, dronedarone, estrogen replacement, H2 antagonists, nitrates, statins, fibrates, antifungal medications, verapamil. Members were required to have evidence of these pre-existing conditions in the six months prior to the new dabigatran/warfarin use. The query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of October 19, 2010 to December 31, 2014.  Modular programs are adaptable standardized programs. Results were generated using the Cohort Identification and Descriptive Analysis (CIDA) tool; click here for more information.  Queries were distributed in July 2015. This report includes data from 15 Data Partners.
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    Additional Details
    FDA Center
    Time Period
    October 19, 2010 - December 31, 2014
    Analysis Type
    Population / Cohort
    All individuals with a pre-existing condition of atrial fibrillation
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)